(392 days)
Not Found
No
The summary describes a bioabsorbable implant for rotator cuff repair and does not mention any AI or ML components or functionalities.
Yes
The device is used for rotator cuff repair in shoulder surgery, which is a therapeutic intervention.
No
Explanation: The device is described as an implant used for rotator cuff repair in shoulder surgery, which indicates a therapeutic or restorative function rather than a diagnostic one.
No
The device description explicitly states that the BIODHOC is an implant made of a bioabsorbable polymer, indicating it is a physical hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "an implant used for rotator cuff repair in shoulder surgery." This describes a device that is surgically implanted into the body to treat a condition.
- Device Description: The device is described as an "implant" made of a "bio absorbable polymer." This further confirms it is a physical device intended for internal use.
- IVD Definition: In Vitro Diagnostics (IVDs) are medical devices that are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
The BIODHOC is a surgical implant, not a device used to test samples outside of the body.
N/A
Intended Use / Indications for Use
The BIODHOC is an implant used for rotator cuff repair in shoulder surgery.
Product codes
HTY
Device Description
The BIODHOC is an implant used for rotator cuff repair in shoulder surgery. The BIODHOC is made of poly DL- lactic acid (PLLA) a bio absorbable polymer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
shoulder
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.
0
'JAN 1 5 2004
510(k) SUMMARY FOR SOFT TISSUE FIXATOR
| 510k #: K 024185 | |
|---|---|
| Owner / Operator: | Future Medical Systems, SA. |
| Address: | 265 Route de la Baronne, ST. Jeannet 06640 France |
| Phone: | 011-33-4-92-12-32-56 |
| Fax: | 011-33-4-92-12-48-75 |
| Contact: | Patrick Janin (US Native/ English speaker) |
Official correspondent:
| Company: | Future Medical Systems, Inc. |
|---|---|
| Address: | 504 McCormick Drive, Glen Burnie, MD 21061 |
| Phone: | 410 761 9411 ext. 11 |
| Fax: | 410 760 9422 |
| Contact: | Mr. Steve Janin |
| Date of submission: | December 17th 2002 |
|---|---|
| Name of device: | BIODHOC |
| Common name: | Soft tissue fixator |
| Classification: | MAI. Fastener, Fixation, Biodegradable, Soft tissue |
| Predicate device: | K991009: Biomet, Inc. RC Buttress. |
| K023963: FMS ADHOC CLAW. |
Device intended use, description and substantial equivalence:
The BIODHOC is an implant used for rotator cuff repair in shoulder
surgery. The BIODHOC is made of poly DL- lactic acid (PLLA) a bio absorbable polymer.
The BIODHOC and the predicate device have the same final function. In addition, the small differences in design do not affect the use, safety and effectiveness, between the device and the predicate device.
Based on these similarities and equivalences we believe our BIODHOC and the Biomet RC buttress (K991009) and the FMS ADHOC CLAW (K023963) are substantially equivalent.
1
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping wings.
Public Health Service
JAN 1 5 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Future Medical Systems, SA C/o Mr. Steve Janin Future Medical Systems, Inc. 504 McCormick Drive Glen Burnie, Maryland 21061
Re: K024185
Trade/Device Name: BIODHOC Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HTY Dated: December 17, 2002 Received: October 20, 2003
Dear Mr. Janin:
We have reviewed your Section 510(k) premarket notification of intent to market the device t We have reviewed your Section 910(x) premained is substantially equivalent (for the indications referenced above and nave decemblication and devices marketed in interstate for use stated in the encrosury manteed provinced provice Amendments, or to commerce prior to May 28, 1770, the endentials with the provisions of the Federal Food, Drug, devices that have been recarsified in accessaries who a premarket approval application (PMA). and Cosmetic Act (11ct) that do not require applivity of the general controls of the Act. The You may, merelore, market the dovrees, skejes, skejes, skeless for annual registration, listing of general controls provisions of the Fee networks. In and prohibitions against misbranding and adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it if your device is classified (Sec above) into entrol so a control stations affecting your device can
may be subject to such additional controls. Existing major may be subject to sach additional controller is not of the 21. Parts 800 to 898. In addition, FDA may be found in the extre concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA 3 issuation of a samelies with other requirements of the Act that FDA has made a decertifications administered by other Federal agencies. You must or any Federal statutes and regulations daministers. 07 not limited to: registration and listing (2 l CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set and CFR Fart 607), adomig (21 OFR Part 820); government 820); and if applicable, the electronic forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
2
Page 2 - Mr. Steve Janin
This letter will allow you to begin marketing your device as described in your Scction 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally premance modicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire specific as not a moliance at (301) 594-4639. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Other general monitational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N Wilkerson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510 K Number: K 024185
Page 1 of 1
Device name: BIODHOC soft tissue fixator
INDICATIONS FOR USE:
The BIODHOC is an implant used for rotator cuff repair in shoulder surgery.
(Please do not write below this Line-Continue on another page if needed.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use > M (Per 21 CFR 801.109)
OR Over-The-Counter-Use $\underline{No}$
(Optional Format 1)
fr. Mark M. Milburn
Restorative
Section 3
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